(57 days)
Not Found
No
The description focuses on mechanical safety features (retractable cover, dead-man trigger) and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as an electrocautery pen intended to deliver electrosurgical energy for tissue cutting and coagulation, which directly provides therapeutic action.
No
The device is described as an electrosurgical pen used for tissue cutting and coagulation, which are therapeutic actions, not diagnostic ones. It delivers energy to the surgical site rather than gathering information or identifying a condition.
No
The device description clearly states it is a "sterile, single-use, monopolar electrocautery pen" with physical components like a "retractable cover" and a "dead-man trigger," indicating it is a hardware device with mechanical features, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver electrosurgical energy to the surgery site for tissue cutting and coagulation" in general surgical procedures. This is a therapeutic and surgical function performed directly on the patient's tissue.
- Device Description: The description details a surgical tool (electrocautery pen) used for cutting and coagulating tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used for treatment and manipulation of tissue during a procedure.
N/A
Intended Use / Indications for Use
The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coaqulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.
Product codes
GEI
Device Description
The Cautery Protective Actuation System device is a sterile, single-use, monopolar electrocautery pen intended to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The C-PAS device has a retractable cover, which functions to reduce the risk of inadvertent actuation that can result in burns, fires, patient impalement, or secondary contact from exposure to a hot tip. In the resting position, the cover guards both the tip and the rocker switch, and thereby prevents inadvertent actuation of the device. The "dead-man" trigger forces the user to squeeze the trigger in order to retract the safety cover and thereby access the rocker switch to actuate the monopolar electrocautery pen. The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing Summary
A summative human factors validation study was conducted in compliance with the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The purpose of this study was to assess the impact of the safety cover of the usability of the device and validate that the intended users can safely and effectively utilize the subject device with support from its Instructions for Use. The study showed that the addition of the safety cover to the subject device does not introduce a new risk for either the clinician or the patients and that intended users of the subject device can safely and effectively use the subject device with support from its labeling.
Design verification testing was performed to verify the functional and performance requirement specifications for the subject device in alignment with the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020. The compatible electrosurgical unit (ESU) and blade electrode are previously FDA cleared and the specific shape of the buttons and housing are not relevant to the thermal performance of the device. As such, no thermal effects testing was required to demonstrate substantial equivalence.
Additionally, the subject device complies with the following electrical safety performance standards:
- IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092732 Bio Protech, Inc Propencil ESU Pencil
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 6, 2023
Safer Surgeries Medical Devices, LLC % Braddon Linda CEO Secure BioMed Evalutations 7828 Hickory Flat Highway, Suite 120 Woodstock. Georgia 30188
Re: K232407
Trade/Device Name: Cautery Protective Actuation System (CPAS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 10, 2023 Received: August 10, 2023
Dear Braddon Linda:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.06
08:03:54 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Cautery Protective Actuation System (CPAS)
Indications for Use (Describe)
The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coaqulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY:
| Date Prepared | July 26, 2023 |
|---|---|
| Sponsor | Safer Surgeries Medical Devices, LLC |
| Cautery Protective Actuation System (CPAS) | |
| 3883 Rogers Bridge Road Suite 201B | |
| Duluth, GA 30097 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| Justin Gracyalny, MSE | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Cautery Protective Actuation System (CPAS) |
| Common Name | Electrocautery Pencil |
| Code -Classification | GXN |
| 21 CFR 878.4400: Class II | |
| Primary Predicate | K092732 Bio Protech, Inc Propencil ESU Pencil |
| Device Description | The Cautery Protective Actuation System device is a sterile, single-use, |
| monopolar electrocautery pen intended to deliver electrosurgical energy to | |
| the surgery site for tissue cutting and coagulation. The C-PAS device has a | |
| retractable cover, which functions to reduce the risk of inadvertent actuation | |
| that can result in burns, fires, patient impalement, or secondary contact from | |
| exposure to a hot tip. In the resting position, the cover guards both the tip | |
| and the rocker switch, and thereby prevents inadvertent actuation of the | |
| device. The "dead-man" trigger forces the user to squeeze the trigger in order | |
| to retract the safety cover and thereby access the rocker switch to actuate the | |
| monopolar electrocautery pen. The C-PAS device functions identically to a | |
| standard, monopolar electrocautery pen with the additional benefits of a | |
| retractable, protective shield. | |
| Indications for Use | |
| Statement | The Cautery Protective Actuation System (CPAS) is intended for use in |
| general surgical procedures to deliver electrosurgical energy to the surgery | |
| site for tissue cutting and coagulation. The CPAS device includes a safety | |
| cover intended to prevent inadvertent actuation of the monopolar | |
| electrocautery device, and to prevent secondary burns from a hot tip. |
5
Comparison of Technological Characteristics
| Characteristic | Subject Device
Safer Surgeries Medical Devices,
LLC
Cautery Protective Actuation
System (CPAS) | Primary Predicate
Bio Protech, Inc.
PROPENCIL ESU Pencil
K092732 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Product Code | GEI | GEI |
| Classification | 878.4400: Class II | 878.4400: Class II |
| Rx or OTC | Prescription Only | Prescription Only |
| Sterile | Yes, Gamma Sterilized, SAL 10-6 | Yes, Gamma Sterilized, SAL 10-6 |
| Single Use | Yes | Yes |
| Target Tissues | General surgical procedures | General surgical procedures |
| Monopolar
Coagulation | Yes | Yes |
| Monopolar Cutting | Yes | Yes |
| Electrosurgical Unit Information | | |
| Electrosurgical Unit | Compatible with FDA-cleared ESUs | Compatible with FDA-cleared ESUs |
| Neutral Electrode Information | | |
| Neutral Electrodes | N/A - Monopolar device which does
not have neutral electrode | N/A - Monopolar device which does
not have neutral electrode |
| Active Accessory Information | | |
| Bipolar / Monopolar | Monopolar | Monopolar |
| Peak Voltage | 5.5kV | Unknown |
| Connector Type | Standard male 3-prong ESU plug | Standard male 3-prong ESU plug |
| Electrode | Compatible with FDA-cleared blade | Compatible with FDA-cleared blade |
| Configuration | electrodes | electrodes |
| Housing Material | Biocompatible polymer | Biocompatible polymer |
| Miscellaneous Accessories | | |
| Smoke Evacuation
Unit | No | No |
| Retractable Button /
Electrode Cover | Yes | No |
Technological Characteristics
There are no significant technological differences between the subject and predicate devices. Both the subject and predicate device are monopolar, electrosurgical pens that include cutting and cauterization functions. Both devices achieve their intended use via identical means. Minor geometrical and material differences and the addition of a retractable button / electrode cover to the subject device were shown to not raise new questions for safety or effectiveness.
6
Non-Clinical Performance Testing Summary
A summative human factors validation study was conducted in compliance with the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The purpose of this study was to assess the impact of the safety cover of the usability of the device and validate that the intended users can safely and effectively utilize the subject device with support from its Instructions for Use. The study showed that the addition of the safety cover to the subject device does not introduce a new risk for either the clinician or the patients and that intended users of the subject device can safely and effectively use the subject device with support from its labeling.
Design verification testing was performed to verify the functional and performance requirement specifications for the subject device in alignment with the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020. The compatible electrosurgical unit (ESU) and blade electrode are previously FDA cleared and the specific shape of the buttons and housing are not relevant to the thermal performance of the device. As such, no thermal effects testing was required to demonstrate substantial equivalence.
Additionally, the subject device complies with the following electrical safety performance standards:
- IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for ● the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.